EPF joins European health organisations to protect patient data in the Digital Omnibus
European Patients’ Forum (EPF) has joined a coalition of European health and consumer organisations calling on EU legislators to ensure that the Digital Omnibus does not weaken the protection of patients’ personal data.
The joint statement recognises the potential of digitalisation to improve healthcare, support safer use of medicines, increase access to services and foster innovation. At the same time, it stresses that regulatory simplification must not come at the expense of fundamental rights, patient confidentiality, professional secrecy or trust in healthcare.
Health-related data are particularly sensitive and extend beyond information explicitly identified as health data. Information about a person’s health can also be inferred from online searches and purchases, consultations, pharmacy interactions, wearables, apps and other connected services. The coalition therefore calls for these data to remain subject to strong protections under the General Data Protection Regulation (GDPR), including when used in digital services, research and artificial intelligence systems.
In the joint statement, EPF and its partners call for:
- strong protection of health data, including genetic and biometric data and information from which a person’s health status can be inferred;
- appropriate safeguards for the use of patient data in AI, including clear legal bases, accountability and measures preventing unrelated commercial uses;
- protection against tracking, profiling and commercial exploitation, particularly when people access health, medicine or pharmacy-related information online;
- continued safeguards for pseudonymised health data, recognising that pseudonymisation does not necessarily make information anonymous;
- meaningful human oversight of automated decisions that could affect patients, including decisions concerning access to, recommendation, pricing or marketing of medicines and pharmacy services;
- support for responsible digital innovation without weakening fundamental rights, privacy or confidentiality.
The statement underlines that innovation in healthcare must be built on trust. Weakening privacy, confidentiality or data protection could affect patients’ willingness to use digital health services and share information with healthcare professionals. It also calls for a clear distinction between scientific research carried out in the public interest and activities primarily pursuing commercial or business objectives.
The signatories urge the European Parliament and the Council to preserve the protections provided by the GDPR and the ePrivacy framework as essential foundations for patient trust, public health and responsible digital innovation in Europe.
For EPF, preserving patient agency and the patient–healthcare professional relationship is central to this discussion. Digital innovation should enable better and more accessible healthcare while ensuring that decisions affecting patients remain informed, transparent and supported by appropriate human oversight.
